Search Results

Ultrasound imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN. Cardiac. Transesophageal. Pelvic. Neonatal/Adult Cephalic. Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Antares with 4D Basic Imaging is substantially equivalent to the predicates listed herein. The Antares is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, 3D imaging, and 4D Basic Imaging on a CRT display.

The provided document is a 510(k) summary for the SONOLINE Antares Diagnostic Ultrasound System, dated November 20, 2002. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and predefined acceptance criteria against a specific reported performance.

Therefore, the document does not contain information on acceptance criteria for device performance, nor details of a study proving a device meets such criteria in the way requested by the prompt for a new or significantly modified device. Instead, it focuses on demonstrating that the Antares system is substantially equivalent to existing cleared devices and meets relevant safety and technical standards.

Here's why the requested information cannot be fully provided from this document:

• Acceptance Criteria for Performance: In a 510(k) for an ultrasound system, the "performance" typically refers to meeting technical standards (e.g., acoustic output, EMC) and showing that image quality and functionality are comparable to predicate devices. There are no specific clinical performance metrics (like sensitivity, specificity, accuracy) provided with acceptance criteria because it's not a study to establish clinical efficacy or effectiveness for a new indication or technology.
• Study Proving Acceptance Criteria: The document lists the design and safety standards the device meets, but it does not describe a clinical study to "prove" the device meets specific clinical performance acceptance criteria. It mentions "applications" (intended uses) for which the device is cleared, but not the clinical outcomes or performance metrics observed in a study.

Given these limitations, here is a breakdown of the available information in the format requested, with explicit notes about what is not present in the document:

Acceptance Criteria and Device Performance Study (Based on 510(k) Summary)

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for substantial equivalence of an ultrasound system, the "acceptance criteria" are primarily related to safety and technical standards, and its performance is deemed acceptable if it is substantially equivalent to predicate devices for its stated intended uses. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or discrete acceptance criteria like those found in a clinical performance study.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable/not provided. This document describes a premarket notification for substantial equivalence, not a clinical performance study of the device against a test set of patient data to measure clinical metrics. The focus is on technical specifications and comparison to predicates.
• Data Provenance: Not applicable/not provided for clinical performance testing. The "data" provided generally relates to technical design and regulatory compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not applicable. There is no mention of a test set of patient data with ground truth established by experts in this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not described or referenced in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on demonstrating improved diagnostic effectiveness with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI component being evaluated for standalone performance.

7. The type of ground truth used:

• Not applicable. No clinical ground truth is described as part of assessing the device for clearance in this document. The equivalence relies on the device meeting established standards and having similar performance characteristics and intended uses to previously cleared devices.

8. The sample size for the training set:

• Not applicable. This document pertains to the regulatory clearance of a diagnostic ultrasound system based on substantial equivalence, not the development or evaluation of an AI algorithm with a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set is described.

Summary of Information from the Document:

The 510(k) summary for the SONOLINE Antares Diagnostic Ultrasound System primarily focuses on demonstrating substantial equivalence to predicate devices (SONOLINE® Elegra Millennium Enhanced, Voluson 730 4D Diagnostic Ultrasound System) for its safety, technology, and intended uses.

• Acceptance Criteria: Compliance with various safety and technical standards (e.g., UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, European Medical Devices Directive, IEC 1157, ISO 10993) is the primary "acceptance criterion" type mentioned. The post-clearance requirement for acoustic output measurements also implies adherence to specific acoustic safety limits.
• Study/Evidence: The "study" mentioned isn't a clinical trial with performance metrics but rather the demonstration that the device's design, technology, and intended uses are substantially equivalent to currently marketed devices and that it meets established safety standards. The document states, "The Antares has been designed to meet the following product safety standards."
• Clinical Performance Data: No clinical performance data, test sets, or ground truth information relevant to clinical metrics (like sensitivity or specificity) are provided in this 510(k) summary. The clearance is based on technological characteristics being similar to predicate devices and adherence to recognized standards.

Ask a specific question about this device